NCT07249918Recruiting
Feasibility of Wearables in Dementia Care in Rural Taiwan
Facilitating the Measurement and Treatment of the Behavioral Symptoms of Dementia (BPSD) and Understanding Caregiver Burden Using Wearable Devices in Rural Taiwan - A Dyadic Feasibility Pilot Study
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
Taiwan is becoming a super-aged society, and more older adults are living with Alzheimer's disease. Many people with Alzheimer's experience behavioral and psychological symptoms, such as agitation, sleep problems, or mood changes. These symptoms often lower their quality of life and increase stress for their family caregivers. This study will test two wearable devices in people with Alzheimer's and their caregivers. One device, called Geneactiv, is a wristwatch that tracks daily activity and sleep. The other device, called Re-Timer, is a light therapy eyewear that may help improve sleep and mood. Researchers will look at how easy the devices are to use, whether participants are willing to wear them for several weeks, and whether the light therapy helps reduce sleep problems or caregiver stress. The study will also compare information from questionnaires with information collected by the devices. The results may help researchers design future studies using wearable tools to better support people living with dementia and their caregivers.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 18 Nov 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- China Medical University Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT07249918
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 18 Nov 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any medical condition that may increase risk during participation, including:
- Retinal disease, active use of photosensitizing medications, recent ocular surgery (within 4 weeks), or photosensitivity disorders (e.g., epilepsy).
- Unstable physical or mental condition deemed unsuitable by investigators, such as acute delirium or active respiratory infection (including COVID-19)
Who the study is looking for
- For participants with dementia:
- Clinical diagnosis of probable Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD, based on established diagnostic criteria.
- Presence of at least one prominent behavioral or psychological symptom of dementia (BPSD), including depression, agitation, apathy, or nighttime sleep disturbance.
- Prominent is defined as:
- NPI single-item score ≥ 4 (severity × frequency), or NPI-Q severity score ≥ 2, or PSQI total score ≥ 5 (if sleep disturbance is the main symptom).
- Stable living arrangement or care environment for at least two weeks before enrollment.
- If receiving any pharmacological or non-pharmacological treatments for BPSD, the dosage and frequency must have remained stable for at least two weeks prior to study participation.
- Able and willing to provide informed consent; for those lacking decision-making capacity, consent must be obtained from a legally authorized representative.
- For primary caregivers:
- Adult primary caregiver of the enrolled participant.
- If receiving treatment for caregiver stress, the dosage and frequency must have been stable for at least two weeks before enrollment.
- Willing and able to provide informed consent.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Medical University Beigang Hospital Coordinator of this site? Confirm its status | Beigang | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.